GAO Report: FDA Strayed With Morning-After Pill Approval Process

In considering, and then rejecting, a bid to make the so-called Plan B emergency contraceptive available over the counter, Food and Drug Administration officials employed an "unusual" decision-making process that contravened their normal course of business, according to a new report from the U.S. Government Accountability Office. Plan B, aka the Morning-After Pill, contains a higher dose of the hormones contained in regular birth control pills; when taken within 72 hours of unprotected sex, it can prevent an unwanted pregnancy. According to the GAO report, FDA officials strayed from their rote process in four ways – and may have decided to reject the bid before the scientific evaluation was finished. FDA "high-level management" determined that they would play a major role in the decision-making, decisions typically made by scientists charged with evaluating the prescription-to-OTC switch. "FDA review staff told us that they were told early in the review process that the decision would be made by high-level management," reports the GAO. And "there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed."

Indeed, according to the report, some FDA officials told the GAO that they were told by the FDA commissioner as early as December 2003 that the OTC application would be denied – nearly six months before the denial was issued and at least four months before the scientific review was completed. (Although the GAO has redacted the names of the various officials involved, during the period in question Mark McClellan [son of Texas state comptroller Carole Keeton Strayhorn] served as FDA commissioner and Steven Galson was the acting chief of the FDA's Center for Drug Evaluation and Research.) Although the FDA's joint advisory panel agreed the OTC switch should be approved, on May 6, 2004, Glason rejected the committee's finding and instead signed a "non-approval" letter, denying the switch – the first time in 10 years that the CDER director had rejected the committee's decision.

The official concern that hastened the denial was incomplete data on whether emergency contraceptives are safe for teens – a seemingly pseudo-scientific rationale that the GAO report terms "novel" and contrary to standard agency practice. A second, retooled Plan B OTC application – which would market the drug to women over 17 – is still pending with the FDA. To view the entire report, go to www.gao.gov/cgi-bin/getrpt?GAO-06-109.